Interim results of a multicenter retrospective-prospective observational post-marketing study of Extimia® BIOCAD (INN: empegfilgrastim) to evaluate safety and efficacy in patients with lymphoproliferative diseases receiving cytotoxic therapy

Aim. To assess the efficacy and safety of using the drug Extimia BIOCAD (international nonproprietary name INN: empegfilgrastim) in order to reduce the frequency and duration of neutropenia, the frequency of febrile neutropenia (FN) and infections manifested by FN in patients with lymphoproliferati...

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Autores principales:	Ekaterina S. Nesterova, Tatyana Yu. Klitochenko, Natalya N. Glonina, Natalya V. Fadeeva, Tatyana A. Sannikova, Irina S. Lyalina, Tatyana V. Shelekhova, Dmitrij G. Sherstnev, Sergey V. Voloshin, Vladislav O. Sarzhevskii, Alina A. Hofman, Damir G. Ichshanov, Irina V. Poddubnaya
Formato:	article
Lenguaje:	RU
Publicado:	IP Habib O.N. 2021
Materias:	non-hodgkin’s lymphoma empegfilgrastim pegylated colony-stimulating factor clinical practice prevention of neutropenia Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/f8ac47889d5d41f7a8c9e2650cc5399d
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id	oai:doaj.org-article:f8ac47889d5d41f7a8c9e2650cc5399d
record_format	dspace
institution	DOAJ
collection	DOAJ
language	RU
topic	non-hodgkin’s lymphoma empegfilgrastim pegylated colony-stimulating factor clinical practice prevention of neutropenia Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	non-hodgkin’s lymphoma empegfilgrastim pegylated colony-stimulating factor clinical practice prevention of neutropenia Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 Ekaterina S. Nesterova Tatyana Yu. Klitochenko Natalya N. Glonina Natalya V. Fadeeva Tatyana A. Sannikova Irina S. Lyalina Tatyana V. Shelekhova Dmitrij G. Sherstnev Sergey V. Voloshin Vladislav O. Sarzhevskii Alina A. Hofman Damir G. Ichshanov Irina V. Poddubnaya Interim results of a multicenter retrospective-prospective observational post-marketing study of Extimia® BIOCAD (INN: empegfilgrastim) to evaluate safety and efficacy in patients with lymphoproliferative diseases receiving cytotoxic therapy
description	Aim. To assess the efficacy and safety of using the drug Extimia BIOCAD (international nonproprietary name INN: empegfilgrastim) in order to reduce the frequency and duration of neutropenia, the frequency of febrile neutropenia (FN) and infections manifested by FN in patients with lymphoproliferative diseases receiving myelosuppressive therapy. Materials and methods. This publication presents the interim results of a multicenter retrospective prospective observational post-marketing study of the safety and efficacy of the drug Extimia BIOCAD (INN: empegfilgrastim) in patients with lymphoproliferative diseases receiving cytotoxic therapy (LEGERITY). The interim data analysis included 40 patients with lymphoproliferative diseases (Hodgkins lymphoma, diffuse large B-cell lymphoma, multiple myeloma, primary mediastinal large B-cell lymphoma, follicular lymphoma, chronic lymphocytic leukemia, splenic marginal zone lymphoma), who were treated in ten research centers of the Russian Federation (Moscow, St. Petersburg, regional clinics). The median age of patients was 48 (2172) years, 13/40 (32.5%) patients belonged to the older age group (60 years). Patients had functional status on the ECOG scale of 02 and received at least 2 chemotherapy injections against the background of prophylaxis with empegfilgrastim. Empegfilgrastim was administered at a dose of 7.5 mg subcutaneously once 24 hours after the end of the administration of cytotoxic chemotherapeutic agents. Primary endpoint: frequency of neutropenia 35 degrees of severity; secondary endpoints: frequency of FN; frequency of severe infections (34 stages); frequency of antibiotic prescription; relative dose intensity of therapy of the conducted chemotherapy courses; the incidence of all adverse reactions in patients who received at least one dose of the study drug empegfilgrastim; the incidence of all serious adverse reactions in patients who received at least one dose of the study drug empegfilgrastim; the incidence of CTCAE 5.0 grade 34 HP in patients who received at least one dose of the study drug empegfilgrastim; discontinuation rate of study drug empegfilgrastim due to adverse reactions. Results. The results of this study demonstrate that the incidence of neutropenia of 3 degree of severity after the 1st cycle of chemotherapy developed in 2/40 patients (5%) and as a result of high-dose therapy (R-DHAP). Neutropenia of any severity was reported in 5/40 patients (12.5%). Cases of FN development have not been registered. Severe infections (mucositis, enteropathy, pneumonia, etc.), as well as the use of antibacterial and antifungal drugs during 1 cycle of chemotherapy and in the inter-course period after 1 cycle of therapy were not recorded in any patient. The next course of myelosuppressive therapy was not delayed due to the development of neutropenia in any of the patients during the study. Adverse events, according to the researcher, associated with the use of empegfilgrastim, were registered in 2/40 patients (5%): moderate generalized pain syndrome (diffuse pain) of 1 severity and in one case ossalgia of 2 severity. No serious adverse reactions were reported. Conclusion. The results of the interim analysis of the study demonstrate the high efficacy of the first Russian original pegylated granulocyte colony-stimulating factor empegfilgrastim after a single administration of a fixed dose in the treatment of patients with aggressive and indolent lymphomas. The drug has a favorable tolerance profile in any age group of patients, especially in elderly patients. Administration of empegfilgrastim as a prophylaxis of neutropenia in patients with lymphoproliferative diseases receiving myelosuppressive therapy of varying intensity can reduce the burden on medical personnel, improve patient adherence to treatment, and contribute to the implementation of the therapeutic plan.
format	article
author	Ekaterina S. Nesterova Tatyana Yu. Klitochenko Natalya N. Glonina Natalya V. Fadeeva Tatyana A. Sannikova Irina S. Lyalina Tatyana V. Shelekhova Dmitrij G. Sherstnev Sergey V. Voloshin Vladislav O. Sarzhevskii Alina A. Hofman Damir G. Ichshanov Irina V. Poddubnaya
author_facet	Ekaterina S. Nesterova Tatyana Yu. Klitochenko Natalya N. Glonina Natalya V. Fadeeva Tatyana A. Sannikova Irina S. Lyalina Tatyana V. Shelekhova Dmitrij G. Sherstnev Sergey V. Voloshin Vladislav O. Sarzhevskii Alina A. Hofman Damir G. Ichshanov Irina V. Poddubnaya
author_sort	Ekaterina S. Nesterova
title	Interim results of a multicenter retrospective-prospective observational post-marketing study of Extimia® BIOCAD (INN: empegfilgrastim) to evaluate safety and efficacy in patients with lymphoproliferative diseases receiving cytotoxic therapy
title_short	Interim results of a multicenter retrospective-prospective observational post-marketing study of Extimia® BIOCAD (INN: empegfilgrastim) to evaluate safety and efficacy in patients with lymphoproliferative diseases receiving cytotoxic therapy
title_full	Interim results of a multicenter retrospective-prospective observational post-marketing study of Extimia® BIOCAD (INN: empegfilgrastim) to evaluate safety and efficacy in patients with lymphoproliferative diseases receiving cytotoxic therapy
title_fullStr	Interim results of a multicenter retrospective-prospective observational post-marketing study of Extimia® BIOCAD (INN: empegfilgrastim) to evaluate safety and efficacy in patients with lymphoproliferative diseases receiving cytotoxic therapy
title_full_unstemmed	Interim results of a multicenter retrospective-prospective observational post-marketing study of Extimia® BIOCAD (INN: empegfilgrastim) to evaluate safety and efficacy in patients with lymphoproliferative diseases receiving cytotoxic therapy
title_sort	interim results of a multicenter retrospective-prospective observational post-marketing study of extimia® biocad (inn: empegfilgrastim) to evaluate safety and efficacy in patients with lymphoproliferative diseases receiving cytotoxic therapy
publisher	IP Habib O.N.
publishDate	2021
url	https://doaj.org/article/f8ac47889d5d41f7a8c9e2650cc5399d
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spelling	oai:doaj.org-article:f8ac47889d5d41f7a8c9e2650cc5399d2021-11-30T17:03:34ZInterim results of a multicenter retrospective-prospective observational post-marketing study of Extimia® BIOCAD (INN: empegfilgrastim) to evaluate safety and efficacy in patients with lymphoproliferative diseases receiving cytotoxic therapy1815-14341815-144210.26442/18151434.2020.4.200492https://doaj.org/article/f8ac47889d5d41f7a8c9e2650cc5399d2021-02-01T00:00:00Zhttps://modernonco.orscience.ru/1815-1434/article/viewFile/61160/44249https://doaj.org/toc/1815-1434https://doaj.org/toc/1815-1442Aim. To assess the efficacy and safety of using the drug Extimia BIOCAD (international nonproprietary name INN: empegfilgrastim) in order to reduce the frequency and duration of neutropenia, the frequency of febrile neutropenia (FN) and infections manifested by FN in patients with lymphoproliferative diseases receiving myelosuppressive therapy. Materials and methods. This publication presents the interim results of a multicenter retrospective prospective observational post-marketing study of the safety and efficacy of the drug Extimia BIOCAD (INN: empegfilgrastim) in patients with lymphoproliferative diseases receiving cytotoxic therapy (LEGERITY). The interim data analysis included 40 patients with lymphoproliferative diseases (Hodgkins lymphoma, diffuse large B-cell lymphoma, multiple myeloma, primary mediastinal large B-cell lymphoma, follicular lymphoma, chronic lymphocytic leukemia, splenic marginal zone lymphoma), who were treated in ten research centers of the Russian Federation (Moscow, St. Petersburg, regional clinics). The median age of patients was 48 (2172) years, 13/40 (32.5%) patients belonged to the older age group (60 years). Patients had functional status on the ECOG scale of 02 and received at least 2 chemotherapy injections against the background of prophylaxis with empegfilgrastim. Empegfilgrastim was administered at a dose of 7.5 mg subcutaneously once 24 hours after the end of the administration of cytotoxic chemotherapeutic agents. Primary endpoint: frequency of neutropenia 35 degrees of severity; secondary endpoints: frequency of FN; frequency of severe infections (34 stages); frequency of antibiotic prescription; relative dose intensity of therapy of the conducted chemotherapy courses; the incidence of all adverse reactions in patients who received at least one dose of the study drug empegfilgrastim; the incidence of all serious adverse reactions in patients who received at least one dose of the study drug empegfilgrastim; the incidence of CTCAE 5.0 grade 34 HP in patients who received at least one dose of the study drug empegfilgrastim; discontinuation rate of study drug empegfilgrastim due to adverse reactions. Results. The results of this study demonstrate that the incidence of neutropenia of 3 degree of severity after the 1st cycle of chemotherapy developed in 2/40 patients (5%) and as a result of high-dose therapy (R-DHAP). Neutropenia of any severity was reported in 5/40 patients (12.5%). Cases of FN development have not been registered. Severe infections (mucositis, enteropathy, pneumonia, etc.), as well as the use of antibacterial and antifungal drugs during 1 cycle of chemotherapy and in the inter-course period after 1 cycle of therapy were not recorded in any patient. The next course of myelosuppressive therapy was not delayed due to the development of neutropenia in any of the patients during the study. Adverse events, according to the researcher, associated with the use of empegfilgrastim, were registered in 2/40 patients (5%): moderate generalized pain syndrome (diffuse pain) of 1 severity and in one case ossalgia of 2 severity. No serious adverse reactions were reported. Conclusion. The results of the interim analysis of the study demonstrate the high efficacy of the first Russian original pegylated granulocyte colony-stimulating factor empegfilgrastim after a single administration of a fixed dose in the treatment of patients with aggressive and indolent lymphomas. The drug has a favorable tolerance profile in any age group of patients, especially in elderly patients. Administration of empegfilgrastim as a prophylaxis of neutropenia in patients with lymphoproliferative diseases receiving myelosuppressive therapy of varying intensity can reduce the burden on medical personnel, improve patient adherence to treatment, and contribute to the implementation of the therapeutic plan.Ekaterina S. NesterovaTatyana Yu. KlitochenkoNatalya N. GloninaNatalya V. FadeevaTatyana A. SannikovaIrina S. LyalinaTatyana V. ShelekhovaDmitrij G. SherstnevSergey V. VoloshinVladislav O. SarzhevskiiAlina A. HofmanDamir G. IchshanovIrina V. PoddubnayaIP Habib O.N.articlenon-hodgkin’s lymphomaempegfilgrastimpegylated colony-stimulating factorclinical practiceprevention of neutropeniaNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282RUСовременная онкология, Vol 22, Iss 4, Pp 77-84 (2021)

Interim results of a multicenter retrospective-prospective observational post-marketing study of Extimia® BIOCAD (INN: empegfilgrastim) to evaluate safety and efficacy in patients with lymphoproliferative diseases receiving cytotoxic therapy

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